Acoustic Radiation Force Impulse (ARFI) Ultrasound for Noninvasive, Diagnostic Atherosclerosis Imaging

NCT01581385 | Completed

• 2 other identifiers: 09-1049R01HL092944
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

This is a pilot clinical trial to assess the ability of a new ultrasound-based imaging method, Acoustic Radiation Force Impulse (ARFI) ultrasound, to describe the composition and structure of atherosclerotic plaques. The hypothesis being tested is that in vivo, transcutaneous ARFI ultrasound delineates plaque composition and structure in human carotid arteries.

Conditions

Atherosclerosis

Keywords

atherosclerosis; carotid artery; carotid endarterectomy

Outcome Measures

Primary Outcomes (1)

• ARFI AUC score

  Statistical area under the curve (AUC) scores will be calculated using trained readers and spatially matched pathologist's interpretation of histochemical data. AUC scores will be determined for each of the four ARFI beam sequences implemented in this study with respect to characterizing calcium deposits, lipid/necrotic core, fibrous caps, collagen deposits, elastin deposits, disrupted internal elastic lamina, and thrombus.

  baseline

Secondary Outcomes (2)

• ARFI sensitivity

  baseline

• ARFI specificity

  baseline

Study Arms (1)

Carotid endarterectomy

Adult patient volunteers, male and female, undergoing clinically indicated carotid endarterectomy surgery.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult (18 years or older) male and female patients scheduled to undergo clinically indicated carotid endarterectomy surgery.

You may qualify if:

• Patients scheduled to undergo clinically indicated carotid endarterectomy
• Determination of clinical need for carotid endarterectomy will be made by the vascular surgeons on this protocol, but the general criteria include symptomatic carotid disease with a stenosis or lesion in the carotid artery thought to be the source of emboli or asymptomatic carotid artery disease with a \> 60% internal carotid artery stenosis in the ipsilateral (surgical) artery.
• Male or Female
• \>18 years of age with no upper limit
• Ability to provide informed consent
• Surgeon's approval
• Any ethnicity or race (meeting all other criteria)

You may not qualify if:

• Inability to communicate in English
• Inability to provide valid consent
• Inability to remain motionless for at least 15 minutes
• Carotid arteries deeper than 35 mm
• Pregnancy\*
• Pregnant women will be excluded from this study because carotid dissection is more likely than carotid plaque in women of child-bearing age.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

The University of North Carolina at Chapel Hill Hospitals

Chapel Hill, North Carolina, 27599, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plaque specimens extracted during clinically indicated carotid endarterectomy surgery will be sectioned and histochemically processed.

MeSH Terms

Conditions

Atherosclerosis

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Caterina M Gallippi, Ph.D.

  UNC Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2012
• First Posted: April 20, 2012
• Study Start: April 1, 2012
• Primary Completion: May 31, 2020
• Study Completion: May 31, 2020
• Last Updated: May 17, 2021

Record last verified: 2021-05

Locations

US (1)